Life Cycle of a Drug
This module explains the drug development process, from discovery to post-market monitoring, including FDA involvement, industry structure, and key regulations […]
Legal Teams
FDA’s Marketing and Labeling Laws
This training covers FDA regulations for drug/device promotion, including labeling requirements, advertising rules and social media compliance. Suggested For: Compliance
Risk Evaluation and Mitigation Strategy (REMS)
Explains the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, including requirements for high-risk drugs, compliance, and post-market safety monitoring.
The CAN-SPAM Act
This training explains CAN-SPAM rules for commercial emails, including opt-out requirements, sender identification, and penalties. Suggested For: Compliance Officers Field
State Consumer Privacy Laws
An overview of state consumer privacy laws, including GDPR-inspired regulations and health data acts like Washington’s My Health, My Data
The FDA’s Office of Prescription Drug Promotion (OPDP)
Learn about FDA regulations for prescription drug advertisements, including risk disclosure requirements, fair balance, and differences between broadcast and print
Anti-Kickback Statute (AKS)
This module details AKS prohibitions on remuneration to HCPs, safe harbors, and high-risk activities. Participants will review enforcement cases and
False Claims Act (FCA)
Provides an overview of the FCA, including false claim standards, whistleblower provisions, penalties, and its impact on the pharmaceutical industry.
STARK Law
Covers the Stark Law’s prohibitions on physician self-referrals for designated health services, exceptions, and penalties for non-compliance. Suggested For: Compliance
HIPAA Security Rule
This module outlines the HIPAA Security Rule’s standards for protecting electronic Protected Health Information (PHI). Participants will learn about administrative,